510(k) K884942

MONAGHAN RVM, MODEL 761 by Monaghan Medical Corp. — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1989
Date Received
November 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type